Track 1 – Advances in Therapeutic Development Across Modalities

(M1030-01-01) Measuring Free IgE in Low-Affinity Interaction with Omalizumab Using an Automated Microfluidic Immunoassay to Support Pharmacokinetics and Pharmacodynamics Studies

(T1030-01-01) Selectivity of Human Cytokine Quantification in Human and Cyno Serum Using a Fully Automated Microfluidic Immunoassay System

(M1030-01-02) Identification and Characterization of Impurities in Lipid Nanoparticle Components Using TOF-MS with Predictive In Silico Fragmentation and Automated Data Processing

(T1030-01-02) Modification of Particle and Hardware Surfaces for Efficient Biotherapeutic Method Development

(T1030-01-03) Tolerization with a Novel Tim Agonist Dual-Acting Liposomal Formulation Prepares the Immune System for the Success of Gene Therapy

(M1030-01-04) Comprehensive Assessment of Immunogenicity Risk of Host Cell Proteins in Biologics Using In Silico and In Vitro Methods

(T1030-01-04) Short-Term Tacrolimus/Sirolimus Combination Therapy Induces Long-Term Immune Tolerance to a Human Monoclonal Antibody in Rats

(T1030-01-05) Assessing the Feasibility and Impact of Singlicate-Based Analysis for Clinical ADA Sample Analysis

(M1030-01-05) Use of Technical Replicate Precision Acceptance for qPCR- and ddPCR-based Validations and Sample Testing

(T1030-01-06) Detection and Quantification of AAV Genome: Effects of Sample Pretreatment and Cross Platform Comparison of ddPCR and qPCR

(M1030-01-06) Investigating the Impact of a Soluble Target on ADA Measurements in a Bispecific Antibody Clinical Study

(M1030-01-07) E. coli Nissle 1917-Based Bacterial Cell Therapy Helps Restore Intestinal Barrier and Improve Post-Myocardial Infarction Outcomes

(T1030-01-07) Evaluation of Formation of SpyTag Form of Botulinum Toxin A (BoNT/A) by Electrochemiluminescence Sandwich Immunoassay

(M1030-01-08) Quantitation of Diazepam and Its Metabolites Using High-Throughput Rapidfire Mass Spectrometry

(T1130-01-01) Strategies for Measuring Oligonucleotides Using a Fully Automated Microfluidic Immunoassay System

(T1130-01-02) Evaluating a Merged Well Analysis Strategy for Validation of a Cellular Kinetics Assay to Quantify an Allogeneic Cell Product in Human Blood by ddPCR

(M1130-01-02) Multiscale Pharmacokinetic Modeling and Simulation of Local and Systemic Exposure of Intramuscularly Injected LNPs

(T1130-01-04) Validation of an Anti-drug Antibody (ADA) Assay Using the Mitra VAMS Microsampling Technology in Support of a Phase I Clinical Study

(M1130-01-04) XenoImmune™ Mouse Model, a Novel and Proprietary Animal Model that Recapitulates Clinical Immunogenicity Rates of Biologics

(M1130-01-05) Multi-factored Immunogenicity Risk Assessment Approach for Bispecific Immune Cell Engagers

(T1130-01-06) Development and Optimization of Next-Generation Lipid Nanoparticles for In Situ CAR-T Production

(M1130-01-07) Characterization of Critical Reagents Used in Immunogenicity Analysis: Case Studies from NAb Assays

(T1130-01-07) Current Strategies for Using Commercial Kit in Regulated Bioanalysis

(M1130-01-08) Establishment of a Generic ADA Assay for Detection of Anti-Drug Antibody Specific to Human IgG Derived Drug Candidate in Murine Serum Samples

(T1130-01-08) Labelling AAV5 Capsid Reduced Its Binding Affinity to the Anti-AAV5 Antibody in Non-primate Human Serum Samples

(M1130-01-09) Development of an In Vitro Cell Culture Model for Evaluation of Influenza Vaccine Formulated Using Spray-Dried Albumin Nanoparticles

(T1130-01-09) Effect of Different Types of Dendrobium on the Gut Microbiota Alteration and Anti-diabetic Effect: In Vitro Screening and In Vivo Verification in db/db Mice

(M1330-01-01) Developing a Generic ADA Assay for the Detection of Circulating Immune Complexes Using a Fully Automated Microfluidic Immunoassay System

(T1330-01-01) ST266 Amnion-Derived Mutipotent Cell Secretome for Prevention and Treatment of Necrotizing Enterocolitis

(M1330-01-02) A Robust Adoptive Cell Therapy Phenotyping Panel for Assessing Cerebrospinal Fluid During and After Neurotoxicity by Flow Cytometry

(T1330-01-02) Screening and Epitope Binning of Anti-idiotypic Antibodies against Therapeutic Bispecific Antibodies Using the Gyros Immunoassay Platform

(T1330-01-03) Harnessing Dendritic Cell Migration as a Predictor of Subcutaneous Immunogenicity Risk in a Mechanism-Based Screening Tool

(T1330-01-04) Characterization and In Vivo Evaluation of Oil Based Anti-adhesion Agent with Xanthan Gum

(M1330-01-04) High-Throughput and Selective LC-MS Quantitation of SMARCA2/4 for SMARCA2 Targeted Protein Degrader Cross-Species Pharmacodynamics Analysis

(M1330-01-05) Application of Mitra Microsampling for the Quantitative Bioanalysis of Antisense Oligonucleotides

(M1330-01-06) In Vitro Assessment of Physicochemical Properties of Biologics for the Early Identification of Pharmacokinetic Liabilities in a Developability Workflow

(T1330-01-06) Validation of PBPK-Based Translation to Predict Monoclonal Antibody Pharmacokinetics in Pediatric Populations

(M1330-01-07) A Translational Approach for Measuring Bi-specific Anti-Drug Antibodies in Non-Clinical Studies Using a Drug Tolerant Generic Plug and Play Format

(T1330-01-07) Preparation and Evaluation of Protein Encapsulated Liposome Using Surfactant for Dry Powder Inhalation

(M1330-01-08) Comparing the Efficacy of Intranasal Midazolam, Diazepam and Lorazepam as First-Line Treatments of Acute Seizures: Pilot Investigation in Pilocarpine-Induced Mice Model

(T1330-01-08) Multiplexed Quantification of CAR-T Subtypes by PCR

(T1430-01-01) Alginate Hydrogels: A Tunable Tool for Biotech Applications

(M1430-01-01) Discrepancies in Adeno-Associated Virus Serotype and Isotype Characterization Positivity Rates in Cynomolgus Serum

(M1430-01-02) Approaches for Reducing the Environmental Impact and Increasing the Throughput of Bioanalytical LC Separations

(M1430-01-03) Achieving Drug Tolerance in a Multiplexed Neutralizing Antibody Assay (nAb) Using Competition and Heat Solid Phase Extraction (SPE) Conditions

(T1430-01-03) Bioanalytical Cross Validation: A More Statistically Based Approach to Establish Differences between Bioanalytical Methods and Laboratories

(T1430-01-04) A Sensitive Electrochemiluminescence-Based Method for the Detection of Anti-drug Antibodies against Anti-PD-1 Antibody Drug Pembrolizumab in Human Serum

(M1430-01-05) Immunocapture LC-MS/MS Assay for the Biomarker, Troponin Fast (TNNI2) Using a Specific Antibody

(T1430-01-05) Mechanistic Investigation of Side-Effects of Lung Tropic Lipid Nanoparticles

(M1430-01-06) Bridging of a Duplex to Singleplex bDNA Method to Quantitate mRNA from LNP-mRNA-ABC in Human Serum

(T1430-01-06) Multiple Root Causes Impact Methionine Oxidation in a Coformulated Drug Product

(M1430-01-08) Antibody Titration: Titer Cut-Point or Screening Cut-Point: Which One Is a Practical Option?

(T1430-01-09) An Orthogonal Bioanalytical Approach to Assess the Immunogenicity and Efficacy of Covid-19 Vaccines